Abbott, a global, broad-based health care company, has reported that the company plans to expand its existing agreement with GlaxoSmithKline Biologicals SA (GSK) to include the development of an additional companion diagnostic test in support of GSK’s cancer immunotherapy research programme.

Companion diagnostic tests are designed to identify specific DNA sequences to help guide physicians in determining which patients are more or less likely to benefit from a particular therapy.

The existing agreements between the two companies, announced in July 2009 and March 2010, focused on the development of PCR (polymerase chain reaction) tests to screen non-small cell lung cancer and melanoma tumours for expression of the MAGE-A3 antigen. Under the expanded agreement, Abbott will develop a PCR test for use on the Abbott m2000rt instrument to screen non-small cell lung cancer tumours for the expression of the PRAME antigen. PRAME is a preferentially expressed antigen of melanoma that is expressed in 69 per cent of non-small cell lung cancer cases, as well as in a wide variety of cancer types, including melanoma, breast, ovarian, and bladder cancer, with limited expression in normal cells.

“This expanded collaboration, along with Abbott’s other recently announced partnerships in oncology, demonstrates the continued commitment Abbott is making to assess biomarkers linked to immunotherapies in various cancers,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business. “This agreement is a testament to the scientific advances Abbott and the industry is making in personalized medicine and companion diagnostics, which are helping ensure the right medicines get to the right cancer patients.”

Abbott’s development efforts in areas such as MAGE-A3 and PRAME will further build its leadership position in cancer diagnostics and personalized medicine. Abbott is a pioneer in the use of molecular tests based on PCR and fluorescence in situ hybridization (FISH) technologies to aid clinicians in the selection of appropriate pharmacogenomic therapies.

GSK’s ASCIs represent a novel class of medicines designed to train the immune system to recognize and eliminate cancer cells in a highly specific manner. These novel cancer immunotherapeutics combine tumour antigens, delivered as purified recombinant proteins, and GSK’s proprietary Adjuvant Systems, which are specific combinations of immunostimulating compounds selected to increase the anti-tumour immune response. ASCIs are being investigated in the clinic to support their use to reduce the risk of tumour recurrence following surgery, or to impact tumour growth in an early metastatic setting. The highly specific mode of action of GSK’s ASCIs allows development of diagnostic tools to aid in selecting patients eligible for the treatment, depending on the expression of the tumour antigens.

MAGE-A3 is a tumour-specific antigen that is expressed in a large variety of cancers, including melanoma, non-small cell lung, head and neck, and bladder cancer, with no expression in normal cells. Expression of the MAGE-A3 gene has been observed in testicular cells but without antigen presentation capabilities. MAGE-A3 protein has been in-licensed by GSK from the Ludwig Institute for Cancer Research, the largest international academic institute dedicated to understanding and controlling cancer.

ASCI is an investigational compound and it is not approved for use in any indication in any country at this time.